The Role:Define and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds (early development, late development, marketed) for the WE Area...
Define and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds (early development, late development, marketed) for the WE Area (including Israel, Turkey and Switzerland). Include fair representation of the interest of EU countries of EMEA.
- Define and implement regulatory strategies, risk assessment & deliverables for early and late development compounds and marketed products in the assigned Therapeutic Area for the WE Area (including Israel, Turkey and Switzerland).
- Identify and advocate region's requirements in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is taken into account at the GRPT.
- Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team to ensure those are met. Duly reports on activities in these teams and alerts TA Head when necessary.
- Develop a Local Regulatory Strategic Tactical Plan in collaboration with the RA personnel in the affiliates. (Area Regulatory Product Team ARPT) to elaborate the region's position on specific projects.
- Coaches and mentors more junior regulatory executives in their project. Transfer knowledge to the Therapeutic Area.
- Primary RA interface with Commercial. Represent RA on the Brand Teams (provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product).
- Primary interface with local health authorities (via RA personnel in the affiliates).
- Responsible for direct liaison with EMA for products within the Therapeutic area. Manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers. Receives delegation to manage EU agency hearings.
- Provide leadership and support to RA personnel in the affiliates (through ongoing communication, assist in the development, training and mentoring of regulatory leaders).
- Assess scientific data provided by specialist units for registration (and re-r) purposes against WE regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses (including CTAs).
- A Degree in pharmacy, biology, chemistry, pharmacology, or related life sciences subject is required.
- Confirmed pharmaceutical industry experience in Regulatory Affairs.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.